Z-0464-2011

DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium

Name: Z-0464-2011 DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium
Creator: AGFA Corp.
Published: 2010-10-08
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2010-10-08 / Terminated / root cause: packaging

FDA source

AGFA Corp. began a recall of DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium on 2010-10-08. The reason FDA records is "Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0464-2011
Status: Terminated
Initiated: 2010-10-08
Posted: 2010-11-26
Terminated: 2010-12-30
Recalling firm: AGFA Healthcare Corp.
Product: DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.
Root cause tag: packaging
FDA root cause: Other
Action: Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.
Quantity in commerce: One unit
Distribution: Nationside Distribution: to NJ.
Product codes and lots: Model 5170/100

Product code MQB

K092238Class IIAgfa Computed Radiography Systems with Dx-G DigitizersAgfa Healthcare N.V. / cleared 2009-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)